Complexity of clinical trial operationalisation in India
Authors: Santhosh Shivabasappa, Akila Srinivasan
Journal: The Lancet Global Health (2022)

Abhinav Bassi and colleagues (March, 2022)1Bassi A Arfin S Joshi R et al.Challenges in operationalising clinical trials in India during the COVID-19 pandemic.Lancet Glob Health. 2021; 10: e317-e319Summary Full Text Full Text PDF PubMed Scopus (1) Google Scholar discuss the challenges unique to India in operationalising clinical trials during the COVID-19 pandemic. Ethics committees in India face several challenges, such as lack of adequately trained staff, extensive workload, inadequate space allocated for operations, and a scarcity of administrative support. Committees have difficulty recruiting members who are not affiliated with their team, and seem to function in isolation as self-sufficient bodies that have no communication with the Central Drugs Standard Control Organisation, the Department of Health Research, or other ethics committees.2Thatte UM Marathe PA Ethics committees in India: past, present and future.Perspect Clin Res. 2017; 8: 22-30Crossref PubMed Scopus (16) Google Scholar There is an urgent need to establish a consultative mechanism that enables ethics committee members to raise their concerns, and members should be afforded time to complete their research oversight roles. The cultural and linguistic diversity of India, where more than 22 official languages are spoken, adds to the challenge of maintaining uniformity across different ethics committees. Involvement of health-care units in remote areas and smaller health-care units in the clinical research process is welcome. However, as a result of the fragmented health-care system in India, several barriers exist with regard to expanding the number of research sites.3Rathi S Kalantri SP Ethics of clinical research and practice in India during the Covid-19 pandemic.Indian J Med Ethics. 2020; V: 175-180Crossref PubMed Scopus (1) Google Scholar Any unilateral decision by the Ministry of Health and Family Welfare to involve smaller public health units would be considered an additional burden by the health-care workforce that is already overworked and understaffed. For example, the Central Government Health Scheme wellness centres across India function as general practice units and provide comprehensive primary care.4Indian Council of Medical ResearchGovernment of India.https://www.icmr.gov.in/pdf/tender/archive/EoI_INTENT_v1.pdfDate accessed: January 15, 2022Google Scholar As the first point of contact for registered patients, these units would be ideal for evaluating several interventions at the primary care level. However, a collaborative approach and open dialogue with the health-care workforce would be needed to facilitate their participation in the clinical research process. In the past decade, clinical trials have been the subject of intense scrutiny in India. Trials are often projected as a commercial activity by the media instead of a scientific endeavour to answer public health questions. The discourse has to move towards helping the public make informed choices about trial participation. In this regard, it is commendable that the Indian Council of Medical Research has launched a pan-Indian network of clinical trial sites.4Indian Council of Medical ResearchGovernment of India.https://www.icmr.gov.in/pdf/tender/archive/EoI_INTENT_v1.pdfDate accessed: January 15, 2022Google Scholar The network will conduct large-scale multicentre clinical trials in India in a timely and well-regulated manner. We hope that the network is successful and addresses the crucial research needs of both the country and the world. We declare no competing interests. Challenges in operationalising clinical trials in India during the COVID-19 pandemicThe global outbreak of COVID-19 has had a substantial effect on the conduct of scientific research worldwide. More than 2000 trials registered on ClinicalTrials.gov were terminated because of the challenges of doing clinical research during the pandemic.1 Our research group from the George Institute for Global Health initiated three trials ( NCT04483960 ),2,3 including the hydroxychloroquine prophylaxis evaluation (HOPE) trial in India,2 but encountered several challenges that were unique to India in terms of the operationalisation and execution of these trials. Full-Text PDF Open Access